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10 June 2020 16:19 by Advocate AM Matjila
What the implied warranty of quality in respect of medical devices and personal protective equipment distributed during the COVID-19 Pandemic means
An implied warranty of quality is granted by both the Consumer Protection Act and the Medicines Act. The warranty is a general warranty of quality and, unless a specific claim is made with regards to the product, the consumer should ensure that the products purchased actually work.
Written by Karabo Motsama, Life Sciences Department, Gerhold and van Wyk Attorneys and Conveyancers, for LexisNexis South Africa.
[Durban, 25 May 2020]
The COVID-19 pandemic has caused a surge in demand for Professional Protective Equipment (PPEs), predominantly face masks, protective gloves and hand sanitisers (i.e. antiseptics and germicides). Whilst a warranty of quality is contained in the Consumer Protection Act (the CPA) and the Medicines and Related Substances Control Act, this does not imply that PPE specifically protects a consumer against COVID-19.
Cloth masks will not be considered for the purpose of this article.
Warranty of quality and the CPA
Section 55 (2)(d) of the CPA states “ …. every consumer has a right to receive goods that …….
(d) comply with any applicable standards set under the Standards Act No. 29 of 1993, or any other public regulation”.
Section 56 states that “in any transaction or agreement pertaining to the supply of goods to a consumer, there is an implied provision that the producer or importer, the distributor and retailer each warrant that the goods comply with the requirements and standards contemplated in section 55 of the CPA….”
It is likely that the vast majority of PPEs purchased during the COVID-19 pandemic are purchased by a consumer with the intention to protect the consumer against COVID-19 transmission. Consumers have an expectation that the PPEs that they purchase will meet all standards of quality and safety needed for their protection against infection of the COVID-19 virus. The warranty will always be associated with the expectation for the PPE’s purchased (i) to be reasonably suitable for the purpose for which they were generally intended; (ii) are of good quality and in good working order and free of any defects; (iii) the goods will be useable and durable for a reasonable period of time, (iv) having regards to the use to which they would normally be put and all the surrounding circumstances of their supply.
Other public regulations as referred to in theCPA in respect of PPE’s refer to the regulatory framework of the South African Health Products Regulatory Authority (“SAHPRA”), empowered and articulated by provisions of the Medicines and Related Substances Control Act No. 101 of 1965 (“Medicines Act”).
Medicines and Related Substances Control Act
The Medicines Act, read in conjunction with the General Regulations on medical devices, published in the Government Gazette notice 40480 No. 1515 of 09 December 2016, provides SAHPRA with the regulatory oversight of medical devices including in-vitro diagnostics (IVD’s). SAHPRA is a section 3A public entity that was formed by the South African government to oversee the regulation of health products (i.e. medicines, medical devices and etc)
In terms of section 22C of the Medicines Act, any company or individual intending to manufacture, distribute (import or export) or wholesale medical devices must comply with acceptable quality assurance principles and good manufacturing and distribution practices as the council may determine. Such an entity or individual is required to be licensed by SAHPRA for i) a medical device establishment and ii) medical device registration license, and each medical device will be allocated a classification (i.e. Class A, B, C or D). It should be noted that the face masks, gloves and IVDs used for protection and diagnosis related to COVID-19, fall within the definition of medical devices, and so should be regulated by SAHPRA as per the provisions of the Medicines Act.
The general regulations of medical devices require distributors and manufacturers of face masks, gloves and IVDs to be licensed with two licenses (i.e. medical establishment license and a medical device certificate/license). Additionally, to be licensed, the aforesaid entities should provide the following minimum but not exhaustive information (i) evidence of certification by an accredited conformity assessment body (i.e. ISO 13485: 2016); (ii) copy of instruction for use of each medical device; (iii) copy of labelling and packaging of each medical device. ( See Annexure 1: ISO certification example).
Application of warranty in relation to COVID-19
Whilst PPEs must meet a satisfactory standard of quality, unless a PPE specifically claims to offer some protection against COVID-19, this warranty does not necessarily require protection against COVID-19. For example, a hand sanitizer may claim to protect against most germs, but could possibly be ineffective against COVID-19. Consumers should therefore familiarize themselves with products in order to ensure that they are fit for a particular purpose such as protection against COVID-19.
An implied warranty of quality is granted by both the Consumer Protection Act and the Medicines Act. The warranty is a general warranty of quality and, unless a specific claim is made with regards to the product, the consumer should ensure that the products purchased are fit for the consumer’s purpose.
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